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. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

Garcia‐Burguillo 1996.

Methods Design: randomised, placebo‐controlled, parallel‐group trial
Participants Number assigned: 60 adults (macrolide n = 30, placebo n = 30)
Age in years (mean ± SD): macrolide: 28.3 ± 5.9, placebo: 27.4 ± 6
Setting: secondary care
Interventions Indication: preterm rupture of the amniotic membranes
Type of macrolide: erythromycin ethyl succinate
Route: per oral
Dose per day: 2000 mg
Duration of treatment: 8 days (mean duration of treatment in erythromycin group)
Total treatment dose: 16,000 mg
Outcomes Adverse events stated as an outcome in trial registration/protocol/paper: no
Adverse events ascertainment: unclear
Adverse events: not reported
Antimicrobial resistance: not reported
Death: reported for babies of treated mothers
Funding sources None reported.
Notes Concomitant medication: yes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk Allocation not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unclear blinding as placebo not described
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Only reported on death in babies, which is an objective outcome not influenced by blinding or not
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) High risk Adverse events not stated as an outcome, unclear ascertainment, adverse events not reported (only death in babies).
Other bias Low risk None were identified.